Ablation and Cementoplasty for Painful Bone Lesions

Not Applicable

• Conditions: Bone Lesion; Bone Metastases; Spine Metastases
• Interventions: Procedure: Ablation and Cementoplasty

• Registration Number: NCT04635137
• Lead Sponsor: University of Calgary

Brief Summary

The aim of this research study is to assess the effectiveness of combined ablation and cementoplasty in the treatment of spinal, pelvic, and extraspinal lesions causing pain resistant to conventional treatment at our centre. In particular, the investigator seek to verify the safety and efficacy for multiple primary tumor types and benign lesions as well as encompass multiple measurements of outcome, including visual analog scale (VAS) for pain, opioid and analgesic use, and overall performance scales, combined with cross-sectional imaging follow-up to assess tumor burden, to ascertain a comprehensive Canadian single-centre experience that has been lacking in previous studies.

Detailed Description

Research Question \& Objectives

1. To conduct a prospective, single-centre study of combined ablation and cementoplasty treatment for painful spinal and extraspinal osseous lesions.

2. Report the technical outcome and safety of percutaneous ablation prior to image-guided cementoplasty in a single treatment session.

3. Review the effectiveness and durability of pain control, local tumor control, and the impact on QoL using ablation and cementoplasty in treating spinal/extraspinal osseous tumors.

4. Assess the feasibility and efficacy of ablation and cementoplasty treatment for different primary tumor types and benign lesions.

Research Design

The investigators will conduct a single-centre, single-arm, cohort analysis of all patients who undergo cementoplasty for osseous disease in the department of interventional radiology over a two-year period. This will be a prospective paired comparison study with patients serving as their own controls. Technical success and procedural complications will be monitored and recorded for all patients. All patients will be followed until death or 3 months post-procedure.

The investigators aim to enroll a minimum of 40 patients referred for symptomatic osseous lesions. Bipolar radiofrequency ablation (Osteocool RFA system, Medtronic) or cryoablation (Visual Ice Cryoablation, Boston Scientific) will be performed under CT, ultrasound, or fluoroscopic guidance at the discretion of the treating radiologist, and immediately followed by cement injection. Radiological outcomes, including local tumor control and disease progression, will be assessed by CT imaging immediately post-procedure as well as 3-month follow-up. Clinical outcomes will be evaluated by VAS, analgesic use, and QoL assessment using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) prior to procedure and immediately post-procedure, as well at 1-week, 1-month, and 3-month intervals post-procedure.

Study Timeline

• Study First Submitted: 2020-11-09
• Study First Submitted QC: 2020-11-17
• Study First Posted: 2020-11-18
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-28
• Last Update Posted: 2021-04-30
• Study Start: 2021-06
• Primary Completion: 2022-12
• Study Completion: 2023-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• adult patient with spinal, pelvic, or extraspinal bone lesion
• pain clinically localized to a single region and tumor involvement confirmed with imaging
• life expectancy greater than 3 months
• provision of informed consent

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Exclusion Criteria

• non-correctable coagulation disorder
• systemic or localized infection
• multiple painful lesions requiring different treatment approaches
• neurological deficits or radicular neurological symptoms
• rheumatic disease
• pregnancy
• previous ablation and/or cementoplasty treatment to same lesion

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ablation and Cementoplasty	Ablation and Cementoplasty	All patients undergoing thermal ablation and cementoplasty procedure for one or more painful bone lesion

Primary Outcome Measures

Name	Time	Method
Analgesia	3 months post-procedure	Opioid and non-opioid analgesia use
Pain Scale	3 months post-procedure	Visual Analog Scale; values 0-10 with 0 being no pain and 10 being the worst pain imaginable.
Quality of Life Questionnaire	3 months post-procedure	European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30). The QLQ-C30 is composed of 3 multi-item scales including a functional scale, a global health status/quality of life scale, and a symptom scale. Each scale ranges in score from 0-100 with a higher scale score representing a high/healthy level of functioning, quality of life, and symptomatology/problems, respectively.

Secondary Outcome Measures

Name	Time	Method
Disease Burden	3 months post-procedure	Tumor burden as assessed by CT scan following procedure as compared to pre-procedure scan

Trial Locations

Locations (2)

Foothills Medical Centre; 🇨🇦 Calgary, Alberta, Canada

South Health Campus; 🇨🇦 Calgary, Alberta, Canada